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# Priority Review for Gilead NDA for HIV Combo Therapy
- URL: https://www.fdaweb.com/priority-review-for-gilead-nda-for-hiv-combo-therapy/
- Published: 2017-08-11T12:00:00.000Z
- Updated: 2026-09-14T22:40:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139364

FDA has granted Gilead Sciences a priority review for its NDA for an investigational, fixed-dose combination of bictegravir (50mg), an integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25mg), a dual-NRTI backbone, for treating HIV-1 infection. Gilead filed the NDA with a priority review voucher on 6/12, and the agency has set a user fee review target action date of 2/12/2018\. The submission is supported by data from four Phase 3 studies that evaluated the fixed-dose combination among treatment-naïve patients and among virologically suppressed patients.